Pregnancy PretermNCT02166645
Comparison Between Preterm Infants Who Are Placed on Their Back or Stomach in the Immediate Postextubation Period
A study testing Prone position and Supine position in people with Pregnancy Preterm, run by Uniao Metropolitana de Educacao e Cultura at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether patient positioning (prone and supine positioning) contributes to the success of extubation in the immediate postextubation period of preterm infants. Read more about this study
- Who is it for?
- Ages Up to 36 weeks
- Conditions the study is for
- Pregnancy Preterm
- What is being tested?
- Prone position and Supine position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns less than 37 weeks of gestation age (calculated by doctor using the method of Capurro/Ballard)
- Newborns undergone to invasive mechanical ventilation in the first week of life, for more than 48 hours
Who cannot join
- Newborns who present malformations and clinical or surgical conditions that preclude the positioning in prone or supine after extubation
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Manoel Novaes Hospital
Itabuna, Estado de Bahia, 45603-305
Klênia Corrêa Solis Carrazza, 55 73 3214-4300, kcscarrazza@yahoo.com.br
About this study
Official title: Comparison of Prone and Supine Positioning in the Immediate Postextubation Period of Preterm Infants: a Randomized Controlled Trial Protocol
The purpose of this study is to determine whether patient positioning (prone and supine positioning) contributes to the success of extubation in the immediate postextubation period of preterm infants.
Read the detailed description
This study is double-blinded randomized controlled trial, whose aim is to compare the proportion of successful extubation of preterm infants immediately after the extubation. Methods: Participants will be recruited from neonatal intensive care unit (NICU) and they will be divided into two groups (supine and prone) and positioned in their respective groups after extubation. A clinical evaluation form and a parameters collection form (respiratory rate, heart rate, saturation of peripheral oxygen, fraction of inspired oxygen and temperature) will be used and filled before extubation and 48 hours after by the professional staff of the NICU. It will be considered a successful extubation all participants who staying extubated for 48 hours after extubation.
- Conditions
- Pregnancy Preterm
- Being tested
- Prone position, Supine position
- Keywords
- patient positioning, premature infant, mechanical ventilation, airway extubation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positionOther
Also called Ventral decubitus
Participants of intervention group will be placed in prone position immediately after extubation and positioned over a roll to raise the chest and facilitate diaphragmatic dynamic, with lateralized head and aligned with the trunk, upper and lower limbs flexed and hands near the face, facilitating hand-mouth access.
Supine positionOther
Also called Dorsal decubitus
Participants of control group remain in supine position after extubation and positioned with the head in the midline, with the upper side of the thorax and brought forward and rolls down the legs to promote slight flexion (30-40º) in the hips and knees.
| Study group | Role | What they receive |
|---|---|---|
| Prone position | Experimental | Prone position per 48 hours after extubation Receives: Other: Prone position |
| Supine position | Active comparator | Supine position per 48 hours after extubation Receives: Other: Supine position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful extubation
Measured: 48 hours after extubation
Secondary outcomes (1)
Improvement of parameters
Improvement of parameters (respiratory rate, heart rate, saturation of peripheral oxygen, fraction of inspired oxygen and temperature)
Measured: 48 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pregnancy PretermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uniao Metropolitana de Educacao e Cultura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Luiza Caires Comper, Uniao Metropolitana de Educacao e Cultura
- Investigators
- Maria Luiza Caíres Comper, Master, Principal investigator, Uniao Metropolitana de Educacao e Cultura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166645
- Sponsor's protocol ID
- NCT
- Status last verified
- May 2014
- First submitted
- 14 Jun 2014
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Antunes LC, Rugolo LM, Crocci AJ. [Effect of preterm infant position on weaning from mechanical ventilation]. J Pediatr (Rio J). 2003 May-Jun;79(3):239-44. Portuguese.
PubMed 14506534Bhat RY, Hannam S, Pressler R, Rafferty GF, Peacock JL, Greenough A. Effect of prone and supine position on sleep, apneas, and arousal in preterm infants. Pediatrics. 2006 Jul;118(1):101-7. doi: 10.1542/peds.2005-1873.
PubMed 16818554Jarus T, Bart O, Rabinovich G, Sadeh A, Bloch L, Dolfin T, Litmanovitz I. Effects of prone and supine positions on sleep state and stress responses in preterm infants. Infant Behav Dev. 2011 Apr;34(2):257-63. doi: 10.1016/j.infbeh.2010.12.014. Epub 2011 Mar 9.
PubMed 21392826Oliveira TG, Rego MA, Pereira NC, Vaz LO, Franca DC, Vieira DS, Parreira VF. Prone position and reduced thoracoabdominal asynchrony in preterm newborns. J Pediatr (Rio J). 2009 Sep-Oct;85(5):443-8. doi: 10.2223/JPED.1932. English, Portuguese.
PubMed 19830358Paiva KCA, Beppu OS. Posição prona. J Bras Pneumol. 2005;31(4):332-340.
Richter T, Bellani G, Scott Harris R, Vidal Melo MF, Winkler T, Venegas JG, Musch G. Effect of prone position on regional shunt, aeration, and perfusion in experimental acute lung injury. Am J Respir Crit Care Med. 2005 Aug 15;172(4):480-7. doi: 10.1164/rccm.200501-004OC. Epub 2005 May 18.
PubMed 15901611Sud S, Friedrich JO, Taccone P, Polli F, Adhikari NK, Latini R, Pesenti A, Guerin C, Mancebo J, Curley MA, Fernandez R, Chan MC, Beuret P, Voggenreiter G, Sud M, Tognoni G, Gattinoni L. Prone ventilation reduces mortality in patients with acute respiratory failure and severe hypoxemia: systematic review and meta-analysis. Intensive Care Med. 2010 Apr;36(4):585-99. doi: 10.1007/s00134-009-1748-1. Epub 2010 Feb 4.
PubMed 20130832
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prone and Supine Positioning in the Immediate Postextubation Period of Preterm Infants: a Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT02166645
- Acronym / sponsor ID
- NCT
- Conditions
- Pregnancy Preterm
- Keywords
- patient positioning, premature infant, mechanical ventilation, airway extubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Uniao Metropolitana de Educacao e CulturaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether patient positioning (prone and supine positioning) contributes to the success of extubation in the immediate postextubation period of preterm infants.
Detailed description
This study is double-blinded randomized controlled trial, whose aim is to compare the proportion of successful extubation of preterm infants immediately after the extubation. Methods: Participants will be recruited from neonatal intensive care unit (NICU) and they will be divided into two groups (supine and prone) and positioned in their respective groups after extubation. A clinical evaluation form and a parameters collection form (respiratory rate, heart rate, saturation of peripheral oxygen, fraction of inspired oxygen and temperature) will be used and filled before extubation and 48 hours after by the professional staff of the NICU. It will be considered a successful extubation all participants who staying extubated for 48 hours after extubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone position | Experimental | Other: Prone positionProne position per 48 hours after extubation |
| Supine position | Active comparator | Other: Supine positionSupine position per 48 hours after extubation |
Who may qualify
- Ages
- Up to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newborns less than 37 weeks of gestation age (calculated by doctor using the method of Capurro/Ballard)
- Newborns undergone to invasive mechanical ventilation in the first week of life, for more than 48 hours
Key exclusion criteria (1 listed)
- Newborns who present malformations and clinical or surgical conditions that preclude the positioning in prone or supine after extubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone positionAlso: Ventral decubitusParticipants of intervention group will be placed in prone position immediately after extubation and positioned over a roll to raise the chest and facilitate diaphragmatic dynamic, with lateralized head and aligned with the trunk, upper and lower limbs flexed and hands near the face, facilitating hand-mouth access. | Other | Prone position |
| Supine positionAlso: Dorsal decubitusParticipants of control group remain in supine position after extubation and positioned with the head in the midline, with the upper side of the thorax and brought forward and rolls down the legs to promote slight flexion (30-40º) in the hips and knees. | Other | Supine position |
Primary outcome
Successful extubation
Time frame: 48 hours after extubation
1 secondary outcome
Improvement of parameters
Time frame: 48 hours after extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
- Background: PubMed 14506534Antunes LC, Rugolo LM, Crocci AJ. [Effect of preterm infant position on weaning from mechanical ventilation]. J Pediatr (Rio J). 2003 May-Jun;79(3):239-44. Portuguese.
- Background: PubMed 16818554Bhat RY, Hannam S, Pressler R, Rafferty GF, Peacock JL, Greenough A. Effect of prone and supine position on sleep, apneas, and arousal in preterm infants. Pediatrics. 2006 Jul;118(1):101-7. doi: 10.1542/peds.2005-1873.
- Background: PubMed 21392826Jarus T, Bart O, Rabinovich G, Sadeh A, Bloch L, Dolfin T, Litmanovitz I. Effects of prone and supine positions on sleep state and stress responses in preterm infants. Infant Behav Dev. 2011 Apr;34(2):257-63. doi: 10.1016/j.infbeh.2010.12.014. Epub 2011 Mar 9.
- Background: PubMed 19830358Oliveira TG, Rego MA, Pereira NC, Vaz LO, Franca DC, Vieira DS, Parreira VF. Prone position and reduced thoracoabdominal asynchrony in preterm newborns. J Pediatr (Rio J). 2009 Sep-Oct;85(5):443-8. doi: 10.2223/JPED.1932. English, Portuguese.
- BackgroundPaiva KCA, Beppu OS. Posição prona. J Bras Pneumol. 2005;31(4):332-340.
- Background: PubMed 15901611Richter T, Bellani G, Scott Harris R, Vidal Melo MF, Winkler T, Venegas JG, Musch G. Effect of prone position on regional shunt, aeration, and perfusion in experimental acute lung injury. Am J Respir Crit Care Med. 2005 Aug 15;172(4):480-7. doi: 10.1164/rccm.200501-004OC. Epub 2005 May 18.
- Background: PubMed 20130832Sud S, Friedrich JO, Taccone P, Polli F, Adhikari NK, Latini R, Pesenti A, Guerin C, Mancebo J, Curley MA, Fernandez R, Chan MC, Beuret P, Voggenreiter G, Sud M, Tognoni G, Gattinoni L. Prone ventilation reduces mortality in patients with acute respiratory failure and severe hypoxemia: systematic review and meta-analysis. Intensive Care Med. 2010 Apr;36(4):585-99. doi: 10.1007/s00134-009-1748-1. Epub 2010 Feb 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Luiza Caíres Comper, Master principal investigator
Uniao Metropolitana de Educacao e Cultura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone position and Supine position in people with Pregnancy Preterm, run by Uniao Metropolitana de Educacao e Cultura at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful extubation (time frame: 48 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02166645, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2014.